EMA: Regulatory information – adjusted fees for applications to EMA from 1 April 2019

EMA: Regulatory information – adjusted fees for applications to EMA from 1 April 2019

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019.

Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 inflation rate was 1.7%.

Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published on 1 April 2019. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures.

For annual fees, the anniversary date of the decision granting the marketing authorisation defines the applicable fee and consequently a new fee will be applicable at the time of any anniversary on or after 1 April 2019.

In addition, access to SME incentives for regulatory consultancies has been clarified (human and veterinary medicines).

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.

2019-04-15T08:07:17+00:00 12/04/2019|Categories: News & Events|